Prospective Real-World Clinical Investigation on Dexyane Med® in Adults With Chronic Hand Eczema
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of days to first relapse of HE after being clear or almost clear of hand eczema
研究概览
简要总结
Prospective, descriptive, multicenter, real-world, international clinical investigation. Data collection is based on current clinical practice over a 6-month follow-up period using both electronic Case Report Form (eCRF) and electronic patient diary (specifically designed mobile/Web application). Based on current clinical practice, at least two milestone visits are anticipated with the possibility of intermediary visits in case of flare recurrence:
- inclusion visit (in-person visit) = Baseline = once clear or almost clear of HE after a moderate to severe flare requiring treatment;
- flare visit(s) (in-person or teleconsultation) = potential intermediary visit(s) required by the patient in case of HE flare, anticipated to occur anytime between inclusion visit and end of study visit;
- end of study visit (in-person or teleconsultation) = regular bi-annual visit for patients' follow-up as per clinical practice, anticipated to occur 6 months post-inclusion (-3 / + 1 months).
详细描述
This clinical investigation will be a real-world, post-market, prospective, descriptive, multicenter, and international.
The clinical investigation is expected to take place in European countries (France, Spain, Italy, Portugal, and Germany are currently planned). Approximately 200 adult patients from approximately 35 centers (dermatologist practices) will be enrolled and followed for a total duration of 6 months (-3/+1 month). The aim of the study is to describe the patient's practice of Dexyane MeD® in CHE patients, for whom it has been prescribed either alone or in association with Dexyane insulating barrier cream, with no intention of group comparison.
All consecutive patients with moderate to severe CHE who are clear or almost clear of HE after being treated with topical or systemic treatment and who have been prescribed Dexyane MeD® (alone or in association with Dexyane insulating barrier), will be eligible to participate. The study will not provide or recommend any specific treatment procedures; all decisions regarding treatment of included patients will be made by the treating physician in accordance with their usual clinical practice.
Patients' data will be collected by the investigator from the date of prescription of Dexyane MeD® until the end of the observation period (6 months). All patients will be treated and monitored according to the local clinical practice. Based on a feasibility survey among dermatologists in public and/or private practice, at least two milestone visits are anticipated with the possibility of intermediary visits in case of flare recurrence:
- inclusion visit (in-person visit) = Baseline = once clear or almost clear of HE after a moderate to severe flare requiring treatment;
- flare visit(s) (in-person or teleconsultation) = potential intermediary visit(s) required by the patient in case of HE flare, anticipated to occur anytime between inclusion visit and end of study visit;
- end of study visit (in-person or teleconsultation) = regular bi-annual visit for patients' follow-up as per clinical practice, anticipated to occur 6 months post-inclusion (-3 / + 1 months).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years at inclusion.
- •Patients diagnosed with CHE (all types of HE admitted: contact, irritative, atopic, etc.) as defined as an eczematous process that lasts for more than three months, or relapses twice or more often per year.
- •Patients clear or almost clear of HE at the time of inclusion (i.e., equivalent to a grade 0 or 1 of the IGA scale) after completing treatment (oral or systemic) for a HE flare within the month prior to inclusion.
- •Patients having been prescribed with Dexyane MeD® alone or in association with Dexyane insulating barrier cream (the patient can either be a primo-user or a regular user of Dexyane MeD®).
- •Patients having provided a signed informed consent.
排除标准
- •Patients with another ongoing and evolutive hand skin condition (including psoriasis, and vitiligo).
- •Patient with ongoing systemic immunosuppressive therapy.
- •Patients participating in interventional trials on any investigational drug at the time of inclusion.
- •Patients unable to understand and to comply with the study-related requirements (patient diary to be completed autonomously).
结局指标
主要结局
Number of days to first relapse of HE after being clear or almost clear of hand eczema
时间窗: 6 months
* severity score, and evolution from baseline, of each HE relapse event during the 6-month follow-up using the Investigator Global Assessment (IGA) scale, the modified Total Lesion Symptom Score (mTLSS) and the Chronic Itch Burden Scale * number of relapse events observed per patient during the 6-month follow-up; * number of days between subsequent HE relapse events during the 6-month follow-up; * rate of patients in whom a relapse of HE was observed during the 6-month follow-up.
次要结局
- Description of healthcare resources use due to CHE (consultations and treatment) and impact of CHE on work productivity assessed with the Work Productivity and Activity Impairment (WPAI) questionnaire.(6 months)
- Proportion of patients satisfied with Dexyane MeD® used with or without Dexyane insulating barrier cream, assessed via a specifically adapted questionnaire(6 months)
- Description of demographics and clinical profile of included patients(6 months)
- Description of scores from the Dermatology Life Quality Index (DLQI) at inclusion and at the end of the 6-month follow-up period.(6 months)
- Proportion of patients adhering to the instructions for use(6 months)
- Proportion of patients in whom at least one relevant Adverse Device Effect (ADE) is observed. Relevant ADEs are defined as those leading to Dexyane MeD® or Dexyane insulating barrier cream discontinuation;(6 months)